Home Health Coronavirus (COVID-19) Update: Daily Roundup August 17, 2020 – FDA.gov

Coronavirus (COVID-19) Update: Daily Roundup August 17, 2020 – FDA.gov


For Immediate Release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19. This molecular test is for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect does not require any special type of swab or collection device – a saliva sample can be collected in any sterile container. It is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the…

Read More: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-17-2020

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Source: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-17-2020

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